Clinical Trial Policy

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=38 | meeting_date=2006-12-13

The Centers for Medicare & Medicaid Services is reconsidering its national coverage decision on the Clinical Trial Policy. On September 19, 2000, the Health Care Financing Administration (now the Centers for Medicare & Medicaid Services (CMS)) implemented a Clinical Trial Policy through the NCD process. The Clinical Trial Policy was developed in response to a June 7, 2000 executive memorandum, issued by President Clinton, directing Medicare to pay for routine patient costs in certain clinical trials. The 2000 Clinical Trial Policy requires trials to be "qualified" prior to payment of routine costs. The policy provides for certain trials to be deemed qualified; i.e., those that are approved and funded by a Federal agency or have an IND approval from FDA or are IND exempt. An additional option, the self-certification option, was never implemented. CMS is reconsidering the current Clinical Trial Policy (to be renamed the Clinical Research Policy) to address several issues that have surfaced since its implementation including the need to: Clarify payment criteria for clinical costs in research studies other than clinical trials; Devise a strategy to ensure that Medicare covered clinical studies are enrolled in the National Institute of Health (NIH) clinical trials registry website; Develop criteria to assure that any Medicare covered clinical research study includes a representative sample of Medicare beneficiaries, by demographic and clinical characteristics; Clarify the definitions of routine clinical care costs and investigational costs in clinical research studies including clinical trials; Remove the self-certification process that was never implemented; Clarify the scientific and technical roles of Federal agencies in overseeing IND Exempt trials; Determine if coverage of routine clinical care costs is warranted for studies beyond those covered by the current policy. Clarify how items/services that do not meet the requirements of 1862(a)(1)(A) but are of potential benefit can be covered in clinical research studies as an outcome of the National Coverage Determination process; Clarify whether and under what conditions an item/service non-covered nationally may be covered in the context of clinical research to elucidate the impact of the item or service on health outcomes in Medicare beneficiaries; and Discuss Medicare policy for payment of humanitarian use device (HUD) costs. In CMS' reconsideration of this NCD, we believe there are three overarching goals of the proposed Clinical Research Policy: 1) to allow Medicare beneficiaries to participate in research studies; 2) to encourage the conduct of research studies that add to the knowledge base about the efficient, appropriate, effective, and cost-effective use of products and technologies in the Medicare population, thus improving the quality of care that Medicare beneficiaries receive; and, 3) to allow Medicare beneficiaries to receive care that may have a health benefit, but for which evidence for the effectiveness of the treatment or service is insufficient to allow for full, unrestricted coverage. Meeting these goals will require some clarifications to the current Clinical Trial Policy and may require additional regulatory changes. The Clinical Trial Policy was developed under the authority of section 1862(a)(1)(E) of the Act. This paragraph prohibits payment for items and services that are not reasonable and necessary to carry out the research purposes of section 1142. In other words, it broadens the limitations on the scope of permissible Medicare payments (in section 1862(a)(1)(A) of the Act) to include making payments for what is reasonable and necessary for the Secretary, acting through AHRQ, to carry out research under section 1142. It permits payment for clinical care that is being studied under section 1142 for its effectiveness and appropriateness.

Actions Taken: October 30, 2006 Posted FR notice [PDF, 104KB] announcing December 13, 2006 meeting. November 9, 2006 CMS is extending the deadline for presentations and written comments for the December 13, 2006 MCAC meeting. The new deadline is 5PM EST November 24, 2006. November 22, 2006 CMS posted the roster and the questions to be discussed at the December 13 MCAC meeting. The questions may be further refined before the date of the meeting. Any updates will be posted. CMS is extending the deadline for presentations and written comments for the December 13, 2006 MCAC meeting. The new deadline is 5PM EST November 30, 2006. November 29, 2006 Posted agenda . December 5, 2006 Posted clinical trial background paper [PDF, 90KB]. December 19, 2006 Posted CMS presentation [PDF, 209KB] and score sheet [PDF, 662KB]. February 21, 2007 Posted minutes [PDF, 4MB] and transcript [PDF, 1MB]. Agenda: Federal Register Notice Medicare Evidence Development & Coverage Advisory Committee December 13, 2006 7:30 AM – 4:30 PM CMS Multi-Purpose Room Agenda Alan M. Garber, MD, PhD, Chairperson Alex Krist, MD, Vice-Chairperson Barry Straube, MD- Director, Office of Clinical Standards and Quality Steve Phurrough, MD, MPA, Director, Coverage and Analysis Group Janet Brock and Kimberly Long , Executive Secretaries 7:30 – 8:00 AM Registration 8:00 – 8:30 AM Opening Remarks— B. Straube MD/J.Brock / S. Phurrough, MD, MPA/A.Garber, MD, PhD 8:30 9:15 AM CMS Presentation and Presentation of Voting Questions: S. Phurrough MD, MPA 9:15 – 10:15 AM Scheduled Presentations 10:15 – 10:30 AM BREAK 10:30 – 10:45 AM Open Public Comments Public Attendees who wish to address the panel will be given that opportunity 10:45 – 11:00 AM Panel Questions to Presenters 11:00 – 11:15 PM Charge to the Committee- A. Garber, MD, PhD 11:15 – 12:00 PM Open Panel Deliberations * * * * * * * * * * * 12:00 – 1:00PM LUNCH (on your own) * * * * * * * * * * * 1:00 – 2:30 AM Open Panel Deliberations (cont): Dr. Garber 2:30 – 2:45 PM BREAK 2:45 – 4:15 PM Formal Remarks and Vote The Chairperson will ask each panel member to state his or her position on the questions 4:15 – 4:30 PM Closing Remarks / Adjournment: S. Phurrough MD, MPA/A. Garber MD, PhD 4:30 PM ADJOURN Associated Nca: Clinical Trial Policy (CAG-00071R) Issue: The Centers for Medicare & Medicaid Services is reconsidering its national coverage decision on the Clinical Trial Policy. On September 19, 2000, the Health Care Financing Administration (now the Centers for Medicare & Medicaid Services (CMS)) implemented a Clinical Trial Policy through the NCD process. The Clinical Trial Policy was developed in response to a June 7, 2000 executive memorandum, issued by President Clinton, directing Medicare to pay for routine patient costs in certain clinical trials. The 2000 Clinical Trial Policy requires trials to be "qualified" prior to payment of routine costs. The policy provides for certain trials to be deemed qualified; i.e., those that are approved and funded by a Federal agency or have an IND approval from FDA or are IND exempt. An additional option, the self-certification option, was never implemented. CMS is reconsidering the current Clinical Trial Policy (to be renamed the Clinical Research Policy) to address several issues that have surfaced since its implementation including the need to: Clarify payment criteria for clinical costs in research studies other than clinical trials; Devise a strategy to ensure that Medicare covered clinical studies are enrolled in the National Institute of Health (NIH) clinical trials registry website; Develop criteria to assure that any Medicare covered clinical research study includes a representative sample of Medicare beneficiaries, by demographic and clinical characteristics; Clarify the definitions of routine clinical care costs and investigational costs in clinical research studies including clinical trials; Remove the self-certification process that was never implemented; Clarify the scientific and technical roles of Federal agencies in overseeing IND Exempt trials; Determine if coverage of routine clinical care costs is warranted for studies beyond those covered by the current policy. Clarify how items/services that do not meet the requirements of 1862(a)(1)(A) but are of potential benefit can be covered in clinical research studies as an outcome of the National Coverage Determination process; Clarify whether and under what conditions an item/service non-covered nationally may be covered in the context of clinical research to elucidate the impact of the item or service on health outcomes in Medicare beneficiaries; and Discuss Medicare policy for payment of humanitarian use device (HUD) costs. In CMS' reconsideration of this NCD, we believe there are three overarching goals of the proposed Clinical Research Policy: 1) to allow Medicare beneficiaries to participate in research studies; 2) to encourage the conduct of research studies that add to the knowledge base about the efficient, appropriate, effective, and cost-effective use of products and technologies in the Medicare population, thus improving the quality of care that Medicare beneficiaries receive; and, 3) to allow Medicare beneficiaries to receive care that may have a health benefit, but for which evidence for the effectiveness of the treatment or service is insufficient to allow for full, unrestricted coverage. Meeting these goals will require some clarifications to the current Clinical Trial Policy and may require additional regulatory changes. The Clinical Trial Policy was developed under the authority of section 1862(a)(1)(E) of the Act. This paragraph prohibits payment for items and services that are not reasonable and necessary to carry out the research purposes of section 1142. In other words, it broadens the limitations on the scope of permissible Medicare payments (in section 1862(a)(1)(A) of the Act) to include making payments for what is reasonable and necessary for the Secretary, acting through AHRQ, to carry out research under section 1142. It permits payment for clinical care that is being studied under section 1142 for its effectiveness and appropriateness. Minutes: Download meeting minutes [PDF, 4MB]. Other Material: Transcript 1 Clinical Trial Background Paper CMS Presentation Panel Voting Questions: Download Questions [PDF, 129KB]. Download scoresheet [PDF, 716KB] Roster: Medicare Coverage Advisory Committee Clinical Trial Policy December 13, 2006 Roster Chair: Alan M. Garber, M.D, Ph.D. Director, Center for Primary Care and Outcomes Research Stanford University Vice-Chair: Alexander H. Krist, MD Family Physician Fairfax Family Practice Center Voting Member/Patient Advocate: Nancy Davenport-Ennis, BA CEO Patient Advocate Foundation Voting Members: Wade M. Aubry, M.D. Senior Advisor Health Technology Center Marc L. Berger, M.D. Vice President Outcomes Research & Management Merck & Co. Inc. Mark D. Grant, MD, MPH Senior Scientist BlueCross BlueShield Association Technology Evaluation Center Mark A. Hlatky, MD Professor, Health Research and Policy and Cardiovascular Medicine Stanford University School of Medicine Nora A. Janjan, MD Professor, Dept of Radiation Oncology University of Texas M.D. Anderson Cancer Center Bernard Lo, MD Professor of Medicine University of California San Francisco Sanford J. Schwartz, MD Professor of Medicine, Health Management & Economics University of Pennsylvania Jeremy Sugarman, M.D., M.P.H., M.A. Harvey M. Meyerhoff Professor of Bioethics and Medicine Phoebe R. Berman Bioethics Institute and Department of Medicine Johns Hopkins University Consumer Representative: Linda A. Bergthold, PhD Healthcare Consultant Industry Representative: Michael L. Ryan, PharmD Vice President, Corporate Affairs Amgen, Inc. Guest Expert Panelists: Barbara Alving, MD Director, NHLBI Steven N. Goodman, MD, MHS,PhD Division of Biostatistics John Hopkins School of Medicine Cary Gross, MD Yale University School of Medicine Steven A. Wartman, MD, PhD President/CEO Association of Academic Health Centers Deborah Zarin, MD NIH Director, ClinicalTrials.gov CMS Liaison: Steve E. Phurrough, MD, MPA Director, Coverage and Analysis Group Executive Secretaries: Janet Brock Kimberly Long